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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II DF
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS322
Date Received07/23/2012
Decision Date08/20/2012
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.
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